Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access

NCT06585917 | Enrolling By Invitation DMC

• 1 other identifier: 2024-2377
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. The study population includes adult patients who are candidates for coronary intervention. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure.

Conditions

PCI; Coronary Arterial Disease (CAD)

Keywords

Distal Radial Artery Access; Coronary Intervention; 7F Sheath; 6F Sheath; Radial Artery Occlusion; Non-Inferiority Trial

Outcome Measures

Primary Outcomes (1)

• Radial Artery Occlusion Rate 24 Hours Post-Procedure

  The primary outcome is the rate of radial artery and distal radial artery occlusion 24 hours after the procedure. Occlusion will be determined by the absence of blood flow spectrum in the radial artery as assessed by ultrasound.

  24 hours post-procedure

Secondary Outcomes (11)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  Up to 30 days post-procedure

• Cannulation Success Rate

  During the procedure

• PCI Success Rate

  During the procedure

• Radial Artery Occlusion Rate 30 Days Post-Procedure

  30 days post-procedure

• Major Bleeding Events

  Up to 30 days post-procedure

Study Arms (2)

7F Sheath Intervention Group

EXPERIMENTAL

Participants in this arm will undergo coronary intervention using a 7F thin-walled sheath via distal radial artery access. This group will be used to assess the efficacy and safety of the 7F sheath compared to the 6F sheath.

Device: 7F Thin-Walled Sheath

6F Sheath Control Group

ACTIVE COMPARATOR

Participants in this arm will undergo coronary intervention using a 6F thin-walled sheath via distal radial artery access. This group will serve as the control to compare the outcomes against those of the 7F sheath group.

Device: 6F Thin-Walled Sheath

Interventions

7F Thin-Walled Sheath DEVICE

The 7F Thin-Walled Sheath is used during coronary intervention procedures via distal radial artery access. This device has a smaller outer diameter compared to traditional 7F sheaths, designed to reduce the risk of vascular complications while allowing for the performance of complex coronary interventions.

7F Sheath Intervention Group

6F Thin-Walled Sheath DEVICE

The 6F Thin-Walled Sheath is the standard device used in coronary intervention procedures via distal radial artery access. It is employed as a control in this study to compare its efficacy and safety against the 7F Thin-Walled Sheath.

6F Sheath Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤80 years;
• Height ≤180 cm;
• Distal radial artery diameter ≥1.7 mm;
• Completed distal radial artery angiography and requires coronary intervention;
• Tolerates dual antiplatelet therapy and intraoperative anticoagulant therapy, with no history of related drug allergies;
• Patient consents to participate in the study.

You may not qualify if:

• Acute myocardial infarction requiring emergency PCI;
• Ultrasound-confirmed occlusion of the radial artery on the procedure side;
• Radial artery and distal radial artery anomalies (e.g., small caliber, tortuous, looped vessels) that make the dTRA approach unsuitable;
• Previous bilateral radial artery intervention or surgery;
• No coronary intervention performed after coronary angiography;
• Inability to undergo coronary angiography and intervention due to subjective or objective reasons;
• Coronary lesions requiring the use of a 7F guiding catheter;
• Coronary arteries not suitable for 7F guiding catheter;
• Severe liver or renal insufficiency, unresolved bleeding disorders, or other serious conditions with an expected survival of less than 1 year;
• Currently breastfeeding or known pregnancy.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• Liu M, Du Y, Cui C, Li C, Yu W, Wang H, Song Y, Gao Z, Song L, Zhai J, Yang Y, Yang W, Wu Y, Liu D, Guo J, Heisha N, Liu H, Zhao Y, Zhang F, Tang Y, Zhao Y, Yu M, Zhang B, Yang J, Li R, Li H, Xiong X, Guo X, Li H, Song Y, Duan F, Gao L. Distal Radial Artery Access With 6F and 7F Thin-Walled Sheaths for Coronary Intervention: A Multicentre, Randomized, DRAWS Trial Protocol. Can J Cardiol. 2025 Dec;41(12):2420-2428. doi: 10.1016/j.cjca.2025.09.002. Epub 2025 Sep 13.

  PMID: 40953816 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lijian Gao, PhD. MD.

  Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study uses a Parallel Assignment model, where participants are randomly assigned to one of two groups: the 7F sheath intervention group or the 6F sheath control group. Each group will receive a different size sheath for coronary intervention via distal radial artery access. The study is designed to compare the outcomes between these two groups, with no crossover between groups during the trial. This model allows for a direct comparison of the efficacy and safety between the two sheath sizes under similar clinical conditions.

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: September 30, 2025
• Study Completion: January 30, 2026
• Last Updated: February 25, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)